| Page properties |
|---|
| Title | Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 (NSCLC-SAQ V1.0) |
|---|
| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
|
|---|
| QRS Short Name | |
|---|
| QRS Permission Status | Approved |
|---|
| Team | Lung Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
|---|
| Supplement Version | 1.0 |
|---|
| Status | Final |
|---|
| Date | 20202022-0901-1706 |
|---|
| Notes | - This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
- This instrument is a US FDA Qualified Clinical Outcome Assessment (COA)
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-275 |
|---|
|
instrument.
|
|---|
|
Revision History
| Date | Version |
|---|
| 20202022-0901-1706 | 1.0 |
© 2020 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
1 Introduction
This document describes the CDISC implementation of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 (NSCLC-SAQ V1.0), a patient-reported outcome (PRO) instrument| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-268 |
|---|
|
.
CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
The representation of data collected for this instrument is based
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-221 |
|---|
|
on the Study Data Tabulation Model Implementation Guide (SDTMIG)
Questionnaires (QS) domain
modemodel,| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-222 |
|---|
|
l, which which can be found on the CDISC website at:
https://www.cdisc.org/standards/foundational/sdtmig.
...
The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.
1.1 Representations and Warranties, Limitations of Liability, and Disclaimers
This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.
CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-274 |
|---|
|
any liability for your use of this material.
Although the United Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.
2 Copyright Status
Critical Path Institute owns the copyright for the NSCLC-SAQ V1.0 and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-224 |
|---|
|
Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.
...
- Patient-Reported Outcome (PRO) Consortium - Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Provisional User Manual, Version 6: March 24, 2017.
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-227 |
|---|
|
- McCarrier KP, Atkinson TM, DeBusk KP, Liepa AM, Scanlon M, Coons SJ and on behalf of the Patient-Reported Outcome Consortium. Qualitative Development and Content Validity of the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument. Clinical Therapeutics
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-228 |
|---|
|
2016; 38(4):794-810.
3 The QS Domain Model
3.1 Assumptions for the QS Domain Model
All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the NSCLC-SAQ V1.0 are listed below. This instrument is intended to be administered electronically per the user manual but a paper option exists if electronic administration is not possible. See the user manual for further details.The NSCLC-SAQ V1.0 is a PRO instrument that assesses key symptoms
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-232 |
|---|
|
The NSCLC-SAQ V1.0 is a PRO instrument that assesses key symptoms| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-229 |
|---|
|
229 of advanced non-small cell lung cancer (NSCLC) over the past 7 days as an endpoint measure in clinical trials. | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-230 |
|---|
|
These concept domains are described in the manual which will be received upon user copyright approval.
Each of the 7 items is rated on a 5-point verbal rating scale| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-231 |
|---|
|
from either "No <symptom> at All" to "Very Severe <symptom>", or from "Never" to "Always" , (depending on the item's question structure), relative to either intensity or frequency. For the NSCLC-SAQ V1.0, QSORRES is populated with the text description of the rating scale response chosen.
| Jira |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-232 |
|---|
|
No score is displayed No score is displayed for any item on the instrument in either the paper form or the electronic format; however, the user manual for the CRF includes the standardized representation of 0 zero (e.g., "No Coughing at All”, “No Pain at All”, “Never”) through 4 (e.g., “Very Severe Coughing”, "Very Severe Pain", “Always”). Because (a) electronic administration is expected frequently, (b) instructions are provided in the user manual| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-233 |
|---|
|
for scoring from C-Path's PRO Consortium, and (c) the numeric score for each question is expected to be submitted with the data, CDISC will represent the standardized scores in QSSTRESC and QSSTRESN.
The time period of evaluation for the NSCLC-SAQ V1.0 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the NSCLC-SAQ V1.0 is the past 7 days.
If no response is provided for an item, then QSORRES, QSSTRESC, and QSSTRESN are all set to null and QSSTAT = “NOT DONE”.
A total score, ranging from 0-20, and 5 subscores, not collected on the NSCLC-SAQ V1.0 CRF , but is documented in the user manual, is are considered as captured data and is are not considered as derived in the example below.| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-234 |
|---|
|
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-235 |
|---|
|
These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from user manual.
If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to Y.| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-236 |
|---|
|
However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-237 |
|---|
|
would be null (See SDTMIG Section : 4.1.8.1, Origin Metadata for Variables).
Subscores for the NSCLC-SAQ V1.0 concept domains (e.g., cough) will be derived in the Analysis Data Model (ADaM)If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-238 |
|---|
|
Terminology
QSCAT, jira| false | | server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-239 |
|---|
|
- Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the NSCLC-SAQ V1.0 QS Domain Model
The NSCLC-SAQ V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject 2 subjects collected at the baseline visit for a NSCLC-SAQ V1.0 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.
The table represents the items from the NSCLC-SAQ V1.0 instrument| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-240 |
|---|
|
. Subject 2324-0001 completed all items. Subject 2324-0002 did not do the test. | Jira |
|---|
Rows 14-26 show the subject was not evaluated on this instrument at visit 1. Because the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-241 |
|---|
|
Subtotal and Subtotal and total score calculations are referenced in the copyrighted user manual.| Dataset wrapinfo |
|---|
| title | Subjects missing visit information abbreviate |
|---|
|
The second subject's missing VISITNUM-1 items were abbreviated by representing the first 3 items and then using the "..." approach to indicate that all items up to the last item represented were missing. We would like input regarding whether you (1) agree with this approach or (2) prefer that all items should be listed in the missing-visit use case moving forward. |
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
|---|
| 1 | STUDYX | QS | 2324-P0001 | 1 | NSCLC101 | NSCLC1-Rate Coughing at Worst | NSCLC-SAQ V1.0 | Moderate Coughing | 2 | 2 |
| Y | 1 | | -P7D | | 2 | STUDYX | QS | 2324-P0001 | 2 | NSCLC102 | NSCLC1-Rate Worst Pain in Chest | | Mild Pain | 1 | 1 |
| Y | 1 | 2015-05-15 | -P7D | | 3 | |
|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
|---|
| 1 | STUDYX | QS | 2324-P0001 | 13 | NSCLC101NSCLC103 | NSCLC1-Rate Coughing at Worst Pain Other Than Chest | NSCLC-SAQ V1.0 | Moderate CoughingMild Pain | 21 | 21 |
| Y | 1 | 2015-05-15 | -P7D | | 24 | STUDYX | QS | 2324-P0001 | 24 | NSCLC102NSCLC104 | NSCLC1-Rate Worst Pain in ChestShort of Breath Usual Activities | NSCLC-SAQ V1.0 | Mild PainSometimes | 12 | 12 |
| Y | 1 | 2015-05-15 | -P7D | | 35 | STUDYX | QS | 2324-P0001 | 35 | NSCLC103NSCLC105 | NSCLC1-Rate Worst Pain Other Than ChestHow Often Low Energy | NSCLC-SAQ V1.0 | Mild PainSometimes | 12 | 12 |
| Y | 1 | 2015-05-15 | -P7D | | 46 | STUDYX | QS | 2324-P0001 | 46 | NSCLC104NSCLC106 | NSCLC1-Short of Breath Usual ActivitiesHow Often Tire Easily | NSCLC-SAQ V1.0 | Sometimes | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 57 | STUDYX | QS | 2324-P0001 | 57 | NSCLC105NSCLC107 | NSCLC1-How Often Low EnergyPoor Appetite | NSCLC-SAQ V1.0 | SometimesNever | 20 | 20 |
| Y | 1 | 2015-05-15 | -P7D | | 68 | STUDYX | QS | 2324-P0001 | 68 | NSCLC106NSCLC108 | NSCLC1-How Often Tire EasilyCough Domain Subscore | NSCLC-SAQ V1.0 | Sometimes2 | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 79 | STUDYX | QS | 2324-P0001 | 79 | NSCLC107NSCLC109 | NSCLC1-How Often Poor AppetiteFatigue Domain Subscore | NSCLC-SAQ V1.0 | Never2 | 02 | 02 |
| Y | 1 | 2015-05-15 | -P7D | | 810 | STUDYX | QS | 2324-P0001 | 810 | NSCLC108NSCLC110 | NSCLC1-Total ScorePain Domain Subscore | NSCLC-SAQ V1.0 | 717 | 1 | 71 |
| Y | 1 | 2015-05-15 | -P7D | | 911 | STUDYX | QS | 2324-P0002P0001 | 111 | NSCLC101NSCLC111 | NSCLC1-Rate Coughing at WorstDyspnea Domain Subscore | NSCLC-SAQ V1.0 | NOT DONE | 2 | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 1012 | STUDYX | QS | 2324-P0002P0001 | 212 | NSCLC102NSCLC112 | NSCLC1-Rate Worst Pain in ChestAppetite Domain Subscore | NSCLC-SAQ V1.0 | 0 | 0 | NOT DONE0 |
| Y | 1 | 2015-05-15 | -P7D | | 1113 | STUDYX | QS | 2324-P0002P0001 | 313 | NSCLC103NSCLC108 | NSCLC1-Rate Worst Pain Other Than ChestTotal Score | NSCLC-SAQ V1.0 | | 7 | 7NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | | 1214 | STUDYX | QS | 2324-P0002 | 41 | NSCLC104NSCLC101 | NSCLC1-Short of Breath Usual ActivitiesRate Coughing at Worst | NSCLC-SAQ V1.0 |
|
|
| NOT DONE | Y |
| 1 | |
| | 2015-05-1513 | STUDYX | QS | 2324-P0002 | 52 | NSCLC105NSCLC102 | NSCLC1-How Often Low EnergyRate Worst Pain in Chest | |
|
|
| NOT DONE | Y |
| 1 | 2015-05-15 | 14 |
|
| | 16 | STUDYX | QS | 2324-P0002 | 63 | NSCLC106NSCLC103 | NSCLC1-How Often Tire EasilyRate Worst Pain Other Than Chest | NSCLC-SAQ V1.0 |
|
|
| NOT DONE | Y | 1 | 2015-05-15 | 15 | STUDYX | QS | 2324-P0002 | 7 | NSCLC107 | NSCLC1-How Often Poor Appetite | NSCLC-SAQ V1.0 | NOT DONE |
| 1 |
|
| | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | 26 | Y | 1 | 2015-05-15 | 16 | STUDYX | QS | 2324-P0002 | 813 | NSCLC108 | NSCLC1-Total Score | NSCLC-SAQ V1.0 | |
|
| NOT DONE | Y |
| 12015-05-15 |
|
|
|
|
4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
...